A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Assembly Biosciences
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Updated on 5 August 2020
See if I qualify
body mass index
antiviral drugs
hepatitis
cirrhosis
liver disease
chronic hepatitis
hepatitis b antigen
hepatitis b e antigen
entecavir

Summary

This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.

Details
Condition Hepatitis B, Hepatitis B, chronic hepatitis b
Age 18years - 65years
Treatment Placebo, ABI-H2158, Entecavir (ETV)
Clinical Study IdentifierNCT04398134
SponsorAssembly Biosciences
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Body mass index of 18 - 36 kg/m^2 and body weight 45 kg
HBeAg 500 IU/mL at Screening
In good general health except for chronic HBV infection for 6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA 6 months apart
Lack of cirrhosis or advanced liver disease

Exclusion Criteria

Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir, standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an investigational agent for HBV infection
History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices, hepatic encephalopathy)
History or presence of clinically significant medical conditions requiring frequent medical management or pharmacologic or surgical treatment
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